High-quality standards are our commitment, which are continuously improved by and approved by customers as well.
On the individual amidite level, raw materials are procured and released with risk-based assessment and state-of-the-art physiochemical analysis.
For each amidite, a nitrosamine risk assessment is also made.
Impurities themselves fall into various categories most notably: 1) Critical to the Oligonucleotide quality and 2) Non-critical. The specifications for the amidites are provided by our global customers and implemented at our site. The most important category of impurity is the critical one as they are incorporated into the oligonucleotide during synthesis. These may be impossible to remove and often difficult to detect. These can impact the quality of the final oligo leading to failure of the batch and high cost in revenue and time lost.
Ongoing in-process control is designed to eliminate or minimize reactions which could lead to the creation of impurities.
The basis for quality is the ISO 9001-2015 standard. However, we consider our proprietary testing exceeds this and incorporates most of the GMP practices such as change control, cleaning validation, method validation and supplier qualification. The business of dealing with our partner customers means we have an up-to-date file of what concerns, problems, and impurities we might encounter before we start any process. This knowledge however is a basis only and is no substitute for rigorous scientific QC testing using advanced analytical technologies including HPLC, UPLC, Karl-Fischer, P-NMR and LC-MS at intermediate and final steps.
Purity through complete control of impurity is the end goal of the Amideus brand.
We have realised that Oligonucleotide manufacturers need a specific unique dedicated approach.
For a list of our amidite impurities and reference standards click here